U.S. patent number 5,899,877 [Application Number 08/732,480] was granted by the patent office on 1999-05-04 for one-piece dispensing device for the contamination-free administration of medicaments (cytostatica).
This patent grant is currently assigned to Primed Halberstadt Medizintechnik GmbH. Invention is credited to Harry Leibitzki, Marina Menz, Norbert Neubauer, Sebastian Vogt, Gerhard Wienzek.
United States Patent |
5,899,877 |
Leibitzki , et al. |
May 4, 1999 |
One-piece dispensing device for the contamination-free
administration of medicaments (cytostatica)
Abstract
A one-piece dispensing device for the contamination-free
administration of medicaments (cytostatica) is particularly
suitable for use in ambulant treatment. The invention provides a
connector for connecting medicament (cytostatica) containers to
instruments by which the medicaments are administered. The
connector is designed to prevent, without a complex apparatus,
contamination of the surroundings during connection of the
container and until its disposal. The dispensing device has at
least one coupling member to create a non-releasable connection
with a medicaments container. The coupling member has an insertion
pin and barbed surfaces to accommodate the medicaments container.
The coupling member is non-releasably connected via a tube to a
flexible container which is to be filled with gas. The flexible
container is non-releasably connected to a further tube outlet and
a mechanically actuated stop valve is incorporated in each of the
connecting tubes.
Inventors: |
Leibitzki; Harry (Halberstadt,
DE), Menz; Marina (Jena, DE), Neubauer;
Norbert (Halberstadt, DE), Vogt; Sebastian (Jena,
DE), Wienzek; Gerhard (Halberstadt, DE) |
Assignee: |
Primed Halberstadt Medizintechnik
GmbH (Halberstadt, DE)
|
Family
ID: |
27206544 |
Appl.
No.: |
08/732,480 |
Filed: |
October 15, 1996 |
PCT
Filed: |
April 25, 1995 |
PCT No.: |
PCT/EP95/01547 |
371
Date: |
October 15, 1996 |
102(e)
Date: |
October 15, 1996 |
PCT
Pub. No.: |
WO95/29661 |
PCT
Pub. Date: |
November 09, 1995 |
Foreign Application Priority Data
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Apr 28, 1994 [DE] |
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94 07 022 U |
Jun 29, 1994 [DE] |
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44 22 960 |
Sep 21, 1994 [DE] |
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44 33 669 |
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Current U.S.
Class: |
604/23 |
Current CPC
Class: |
A61J
1/2089 (20130101); A61J 1/10 (20130101); A61J
1/2096 (20130101); A61J 1/201 (20150501); A61J
1/2058 (20150501); A61J 1/1475 (20130101) |
Current International
Class: |
A61J
1/00 (20060101); A61M 037/00 () |
Field of
Search: |
;604/80-81,23,49,53,82-85,30-34,131,151,246,247 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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0028198 |
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May 1981 |
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EP |
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0273015 |
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Jun 1988 |
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EP |
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0327519 |
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Aug 1989 |
|
EP |
|
0330130 |
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Aug 1989 |
|
EP |
|
0363770 |
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Apr 1990 |
|
EP |
|
0416454 |
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Mar 1991 |
|
EP |
|
0548577 |
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Jun 1993 |
|
EP |
|
Primary Examiner: Yasko; John D.
Assistant Examiner: Mendez; Manuel
Attorney, Agent or Firm: Jordan and Hamburg LLP
Claims
We claim:
1. A dispensing device for contamination-free administration of a
drug provided in a drug container with a seal, the dispensing
device comprising:
at least one coupling member for establishing a non-detachable
connection with the drug container, said coupling member including
an insertion pin for penetrating the seal of the drug container and
at least one barb member for engaging the drug container to
establish said non-detachable connection;
a flexible container fillable with a gas;
a first conduit having a first stop valve which is openable and
closeable, said first conduit connecting said coupling member with
said flexible container to permit passage of the drug between said
flexible container and the drug container; and
a second conduit having a second stop valve which is openable and
closeable, said second conduit communicating with said flexible
container for operation as an outlet.
2. The dispensing device as claimed in claim 1 further comprising a
third conduit having a third stop valve which is openable and
closeable, said third conduit communicating with said flexible
container to permit passage of matter into said flexible container
wherein at least said first conduit has said coupling member.
3. The dispensing device as claimed in claim 1 or 2, wherein said
coupling member includes a cup-shaped hollow body encircling and
sealing around said insertion pin, and said cup-shaped hollow body
has a contoured inner surface with said barb member disposed
thereon at a position relative to a tip of said insertion pin such
that the barb member non-detachably engages the drug container
after piercing of the seal of the drug container by said insertion
pin.
4. The dispensing device as claimed claim 3, wherein said coupling
member includes said hollow body, said contoured inner surface, and
said insertion pin, and is manufactured integrally as one
piece.
5. The dispensing device as claimed in claim 1, wherein said
flexible container is a self-supporting gas-filled flexible
container.
6. The dispensing device as claimed in claim 1 or 5, further
comprising a third conduit having a check valve, said third conduit
communicating with said flexible container to permit passage of
matter into said flexible container, said check valve having a
socket for receiving a nozzle to permit supply of variable amounts
of solvents into said flexible container.
7. The dispensing device according to claim 6, wherein said socket
is a Luer-lock joint which opens the check valve.
8. A dispensing device for contamination-free administration of a
drug provided in a drug container with a seal, the dispensing
device comprising:
at least one coupling member for establishing a non-detachable
connection with the drug container, said coupling member including
an insertion pin for penetrating the seal of the drug container and
a coupling mechanism for non-detachably engaging the drug container
to establish said non-detachable connection;
a flexible container fellable with a gas;
a first conduit having a first stop valve which is openable and
closeable, said first conduit connecting said coupling member with
said flexible container to permit passage of the drug between said
flexible container and the drug container;
a second conduit having a second stop valve which is openable and
closeable, said second conduit communicating with said flexible
container for operation as an outlet.
9. The dispensing device as claimed in claim 8 further comprising a
third conduit having a third stop valve which is openable and
closeable, said third conduit communicating with said flexible
container to permit passage of matter into said flexible
container.
10. The dispensing device as claimed in claim 8, wherein said
coupling member includes a cup-shaped hollow body encircling and
sealing around said insertion pin, said cup-shaped hollow body
having a contoured inner surface, and said coupling mechanism
includes a barb member disposed on said contoured inner surface at
a position relative to a tip of said insertion pin such that the
barb member non-detachably engages the drug container after
piercing of the seal of the drug container by said insertion
pin.
11. A dispensing device for contamination-free administration of a
drug provided in a drug container with a seal, the dispensing
device comprising:
at least one coupling member for establishing a non-detachable
connection with the drug container, said coupling member including
an insertion pin for penetrating the seal of the drug container and
a coupling mechanism for non-detachably engaging the drug container
to establish said non-detachable connection;
a flexible container fillable with a gas;
a first conduit having a first stop valve which is openable and
closeable, said first conduit connecting said coupling member with
said flexible container to permit passage of the drug between said
flexible container and the drug container;
a second conduit having a second stop valve which is openable and
closeable, said second conduit communicating with said flexible
container for operation as an outlet; and
a third conduit having a check valve, said third conduit
communicating with said flexible container to permit passage of
matter into said flexible container, said check valve having a
socket for receiving a nozzle to permit supply of variable amounts
of solvents into said flexible container.
12. The dispensing device according to claim 11, wherein said
socket is a Luer-lock joint which opens the check valve.
Description
BACKGROUND OF THE INVENTION
The invention relates to a one-piece dispensing device for
contamination-free administration of medicaments (cytostatica),
particularly for use in ambulant treatment.
For mixing and transferring pharmaceutical solutions from one
container to at least another one it is required to embody the
connection in such a manner that an escape of pharmaceutic agents
and, thus, a contamination of the container surface and of the
health care workers is eliminated. In particular, with respect to
the mixing and administration of highly toxic cytostatic solutions,
which can cause diseases when escaping uncontrolled, a
contamination-free transfer and mixing is required.
According to the state of art, an infusion solution and dry or
liquid form drugs are admixed by a syringe and by removal from and
addition to different containers, before a mixed infusion solution
is ready for infusion. Contaminations cannot be eliminated due to
pressure differentials between the different containers and the
atmosphere, and due to the free handling of the syringe. Such a
practice requires working under a suction apparatus which is
considerably disturbing in medical work.
Furthermore, injection ports on infusion containers have been
proposed which improve the mixing of the agents mentioned but do
not eliminate the problem of contamination. A further improvement
of the same object is known from the EP 0 363 770 A1 which
discloses a connector for pharmaceutic solutions, and from EP 0 330
130 which disclose a container for infusion solutions. The
connector described in the EP 0 363 770 substantially consists of a
tubular coupling portion and a shutoff device for closing the
former. The coupling portion is comprised of a hollow insertion pin
and a hollow portion attached thereto which permits insertion into
a hose-like connector of a container. The hollow portion is closed
by a stop-cock detachable from the outside. However, even when
employing containers having rubber stopper seals, elimination
emission of aerosols is not assured.
Furthermore, connectors are known from the U.S. Pat. No. 4,675,020
and from the EP 0 028 198 which do not solve the problem of
contamination as desired and, additionally, similar to the above
disclosed device, only permit the connection of two containers
filled with pharmaceutic solutions. Thus, such devices are only
applicable when, for example, the dissolving of an agent requires
two solvents.
SUMMARY OF THE INVENTION
It is an object of the invention to provide a connector for joining
drug (cytostatica) containers to an administration system which
eliminates contamination of the environment around the drug
container from the connecting state up to the removal of residuals
and which does so without considerable expenditures for the
connector apparatus.
The present invention provides a connector which is particularly
applicable in ambulant treatment and which, when used, does not put
high requirements upon medical care workers and releases the latter
from any contamination problems.
Briefly stated, the present invention provides a one-piece
dispensing device for the contamination-free administration of
medicaments is particularly suitable for use in ambulant treatment.
The invention provides a connector for connecting medicament
containers to instruments by which the medicaments are
administered. The connector is designed to prevent, without a
complex apparatus, contamination of the surroundings during
connection of the container and until its disposal. The dispensing
device has at least one coupling member to create a non-releasable
connection with a medicaments container. The coupling member has an
insertion pin and barbed surfaces to accommodate the medicaments
container. The coupling member is non-releasably connected via a
tube to a flexible container which is to be filled with gas. The
flexible container is non-releasably connected to a further tube
outlet and a mechanically actuated stop valve is incorporated in
each of the connecting tubes.
In accordance with these and other objects of the invention, there
is provided a one piece dispensing device for contamination-free
administration of drugs (cytostatica) comprising at least one
coupling member for establishing a non-detachable connection with a
drug containing container, the coupling member including an
insertion pin and a barbed area for receiving the drug container,
the coupling member being non-detachably connected via a hose
connection to a receptacle permitting filling with a gas prior to a
first application of the device, the receptacle being
non-detachably connected to a further hose-like outlet, in each of
the connection lines a respective mechanically operable stop valve
being installed.
According to a feature of the invention, the coupling member is
constituted of a cup-shaped inelastic hollow body enclosing and
sealing the insertion pin, and being provided with an interior
reception profile ensuring a non-detachable contact to a drug
container, wherein the height of the tip of the insertion pin
relative to a the barbed area of the reception profile is adapted
to actuate an arresting effect of the barbed area with the drug
container after piercing an insertion base of the latter.
According to a further embodiment of the present invention the is
provided a dispensing device for contamination-free administration
of a drug provided in a drug container with a seal, the dispensing
device comprising: at least one coupling member for establishing a
non-detachable connection with the drug container, the coupling
member including an insertion pin for penetrating the seal of the
drug container and a coupling mechanism for non-detachably engaging
the drug container to establish the non-detachable connection; a
flexible container fillable with a gas; a first conduit having a
first stop valve which is openable and closeable, the first conduit
connecting the coupling member with the flexible container to
permit passage of the drug between the flexible container and the
drug container; a second conduit having a second stop valve which
is openable and closeable, the second conduit communicating with
the flexible container for operation as an outlet.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be explained in more detail by reference to the
following figures wherein:
FIG. 1 shows an embodiment of the present invention for
administering drugs (cytostatica) in liquid form;
FIG. 2 shows an embodiment of the present invention for dissolving
drugs sold in solid form (cytostatica) and for mixing two liquid
drugs;
FIG. 3 shows an embodiment of the present invention for dissolving
drugs sold in solid form, in which a supply means for variable
amounts of solvents is provided; and
FIG. 4 shows a detailed representation of an embodiment of a
one-piece coupling according to the present invention.
DETAILED DESCRIPTION OF THE INVENTION
Referring to FIG. 1, a connector is shown comprising a coupling
member 1 which includes an insertion pin 2. The coupling member 1
is non-detachably connected by adhesives or by welding to a
flexible container 4 via hose connections 3 and 31. The flexible
container 4 is provided to accept filling with a gas. A
mechanically operable stop valve 5 interconnects hose connections 3
and 31. The flexible container 4 also is preferably non-detachably
provided with a hose-like outlet 6 and a further mechanical stop
valve 7 integral with the outlet 6. The outlet 6 provides for
making hose connection (not shown) to patients, such as with
conventional catheters. The coupling member 1 consists of a
cup-shaped inelastic hollow body 11 which has a contoured interior
surface 12. The hollow body 11 is preferably and additionally
coated with an elastic sealing means (not shown). The contoured
interior surface 12 tapers inward and carries at least one barb
member 13.
Referring to FIG. 3, in order to administer a drug (cytostatica)
available in containers having a neck of which permits insertion
into the coupling member 1, a drug container 100 is inserted into
the coupling member 1 and pressed on the latter. Typically the
height of the penetration depth of the insertion pin 2 relative to
the barbed member 13 is so defined that, when the insertion pin 2
has pierced an insertion base of the drug container 100, the barbed
members 13 catch corresponding engagement areas of the neck of the
drug container 100 and thus non-detachably connect the latter to
the coupling member 1. Thus it is ensured that during connection
and infusion subsequently carried out, neither the health care
workers nor the environment is contaminated by aerosols or the like
emitted from the drug container 100.
Referring again to FIG. 1, subsequent to establishment of
connection of the drug container 100, a path is opened via the
mechanically operable stop valve 5 to a sterile flexible container
4 which is, for example, filled with air. It is feasible to press
the air into the drug container 100 and subsequently withdraw a
required dosage of the liquid drug from the container 100 into the
flexible container 4. Only then is the path via the outlet 6 for
the drug to be administered to the patient opened by means of the
stop valve 7. Conduction means attached to the outlet 6,
conventionally connected to an adapter plug nozzle 61 of the outlet
6, are not represented in more detail.
Referring to FIG. 2, a further embodiment of the present invention
is shown which differs from the embodiment of FIG. 1 by a different
embodiment above a line X--X at the hose-connection 31. Typically,
two hose connections 32 branch off from the hose connection 31,
non-detachably connected to the latter. One hose connection 31
includes the mechanically operable stop valve 5 and the other hose
connection includes mechanically operable stop valve 51. In a
preferable embodiment, both of the hose-connections 32 are each
provided with the coupling member 1 in analogy to FIG. 1.
The embodiment of FIG. 2 is particularly suitable for administering
drugs (cytostatica) on sale in dry form, such as powder. The
procedure is as follows
First the first coupling member 1 is connected to a container with
an appropriate solvent inside and, subsequently, the second
coupling member 1 is connected with a container containing the drug
to be passed into solution. After opening the stop valve 51 an
appropriate volume of the solvent passes into the flexible
container 4, the stop valves 7 and 5 being in the OFF-state. Then
the stop valve 51 is closed and the stop valve 5 opened to open the
path to the container with the drug (cytostatica) and pass the
solvent into solution with the drug as the flexible container 4 is
kept under pressure. Subsequent to the above solution process, the
dissolved drug is permitted to return to the flexible container 4.
The valves 5 and 51 are set to the OFF-state and the dissolved drug
can be administered as described in analogy to FIG. 1.
It is obvious also to employ the embodiment shown in FIG. 2 for
dosed mixing of two liquid drugs the containers of which are
connectable to the first and the second coupling members 1.
Referring again to FIG. 3, a particularly advantageous
administering device of the present invention, discussed above with
regard to the coupling member 1 and the insertion pin 2 connecting
with the container 100, has the coupling member 1 non-detachably
connected by adhesives or welding to a flexible gas-filled
self-supporting container 41 via a hose-connection 31. The
mechanically operable stop valve 5 is provided within the
hose-connection 31. Furthermore, in analogy to FIG. 1, the flexible
container 41 is, preferably non-detachably, provided with the
hose-like outlet 6 integrated with the mechanical stop valve 7.
In a further particularly advantageous embodiment of the present
invention, a second hose-connection 321 branches off the first
hose-connection 31, also non-detachably connected with one another.
A check valve 52 is provided in the second hose-connection 321
operating as a mechanical stop valve with the locking effect in
opposite direction to the flexible container 41. The check valve 52
is provided with a socket 521 adapted for receiving a cone-shaped
connection piece 9. The socket 521 preferably is embodied as a
Luer-lock joint which, in particular, is adapted for receiving a
tapering end portion of a conventional syringe. Furthermore, it is
feasible to insert an analogous stop valve 5 between the check
valve 52 and the hose connection 321.
According to the invention, the Luer-lock joint is preferably
embodied in such a manner that the same when inserted into the
check valve 52 opens the latter via the nozzle end-portion 9 of the
syringe when the connection is effected. The proposed solution is
particularly suited for administration of drugs (cytostatica) which
are at one's disposal in dry form, such as powder. The procedure is
as follows:
First the container 100 which contains the drug to be dissolved is
connected by exerting pressure in a direction indicated by the
arrow; the path to the hose connection 31 being still closed by the
stop valve 5. Then a syringe which is conventionally and variably
filled with a sodium chloride solution, depending on the dosage of
the dry form drug to be dissolved, is inserted via its nozzle end
portion 9 into the Luer-lock joint 521 to effect contact with the
same and to open the check valve 52. The solvent is now permitted
to enter the flexible and self-supporting gas-, preferably,
air-filled container 41. Subsequently, the syringe is removed and
the check valve 52 ensures a contamination-free seal preventing
contamination of the surrounding environment.
Alternatively, when it is required that the syringe or any other
replacement container for the solvent remain in the connected
state, a further stop valve is provided between the check valve 52
and the hose connection 31. The further stop valve must be closed
after the solvent has been filled in the flexible container 41.
The first stop valve 5 to the coupling member 1 is then opened and
an appropriate dosage of the solvent is pressed into the container
100 with the drug to be dissolved and, after dissolution, the
solution is transferred into the flexible container 41. the first
stop valve 5 is then closed and the drug container 100 remains in
an airtight and non-detachable connection with the coupling member
1. The release of the dissolved drug to the patient is obtained by
opening the stop valve 7.
It lies within the scope of the invention to embody the stop valve
5 as a three-way valve installed adjacent the flexible container 41
in the hose connection 31.
In contrast to the embodiment according to FIG. 2 where the solvent
for mixing solutions has to be at one's disposal in doses as on
sale and in prepared containers, what might, in particular, involve
difficulties in small medical practices due to the fact that, for
example, sodium chloride solutions as rule are only available in
large fillings, the embodiment according to FIG. 3 has the
advantage that, due to the second connection port, a
contamination-free coupling of a conventional syringe with variable
dosage is feasible. Furthermore, the range of drug doses to be
dissolved is extended at will.
Referring to FIG. 4, a partially sectional view of an embodiment of
the coupling member 1 is shown in detail. All elements designated,
namely, the insertion pin 1, hollow body 11, contoured interior
surface 12, and a connection piece 8, which preferably are made of
plastics, according to the present invention are embodied as one
piece, that is, the insertion pin 2 is also an integral part of the
coupling member 1. Preferably, it is feasible to manufacture the
entire coupling member 1 as a one-piece injection-moulded member.
Notches 21 are also generated with the plastics injection moulding
of the coupling member 1 and are adapted to receive corresponding
counterparts on the drug container.
The present invention is not restricted to the number of
connections disclosed. It, however, is essential that a flexible
container 4, 41 permitting gas filling is employed which is
provided with at least two connection lines to permit a selective
opening and closing to a definitely embodied coupling means and in
direction of the drug delivery, respectively. Typically, the entire
administration system, including an already gas-filled (preferably
air) flexible container is made available in sterile form.
Alternatively, it is feasible to fill the flexible container with a
gas only prior to application.
* * * * *